Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kreativ, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
274 daysmedian FDA review time
524 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990060 | MACH 7 | Kreativ, Inc. | 2000-06-15 | 524 | 0 |
| K983227 | POWER BLOCK | Kreativ, Inc. | 1998-12-11 | 87 | 0 |
| K980216 | KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 | Kreativ, Inc. | 1998-06-16 | 146 | 0 |
| K962376 | KREATIV KURING LIGHT SYSTEM | Kreativ, Inc. | 1997-03-21 | 274 | 0 |
| K940776 | KREATIV MODEL KV-1 | Kreativ, Inc. | 1994-12-21 | 302 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda